Leica Biosystems Richmond Inc.: Medical Device Recall in 2016 - (Recall #: Z-1948-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.

Product Classification:

Class III

Date Initiated: May 6, 2016

Date Posted: June 22, 2016

Recall Number: Z-1948-2016

Event ID: 74178

Reason for Recall:

An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system.

Status: Terminated

Product Quantity: 33 systems

Code Information:

Serial # System 300139 23ADMWS 300157 23ADMWS 300154 23ADMR 300153 23ADMR 300152 23ADMWS 300133 23ADMR 300132 23ADMR 300131 23ASLOMWS 300160 23ADMWS 300127 23AUWS 300128 23ASlDMWS 300151 23ADMR 300150 23ASlDMWS 300155 23ASLDMWS 300159 23ASLOMWS 300129 23ADMR 300156 23ADMWS 300140 23ASLDMWS 300149 23ADMR 300148 23ADMR 300147 23AOMR 300146 23ADMR 300145 23ADMR 300144 23ADMR 300130 23ADMWS 300134 23ASLDMWS 300142 23ASLDMWS 300138 23ASLDMWS 300135 23ADMWS 300136 23ASLDMWS

Distribution Pattern:

U.S. consignees: Nationwide; Foreign Consignees: China, Japan, Russia, Italy and England.

Voluntary or Mandated:

Voluntary: Firm initiated